Kornimate/medical-research-clean huggingface dataset:
topical sunscreen in preventing skin rash in patients receiving drugs such as erlotinib or cetuximab for cancer

Conditions: Dermatologic Complications; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: topical sunscreen may be effective in preventing skin rash caused by treatment with drugs such as erlotinib or cetuximab. it is not yet known whether topical sunscreen is more effective than a placebo in preventing skin rash in patients receiving drugs such as erlotinib or cetuximab for cancer. purpose: this randomized phase iii trial is studying topical sunscreen to see how well it works compared with a placebo in preventing skin rash in patients receiving drugs such as erlotinib or cetuximab for cancer.

objectives: * compare the incidence and severity of erlotinib-, cetuximab-, or other epidermal growth factor receptor inhibitor-induced skin rash development in patients with cancer treated with prophylactic topical sunscreen vs placebo. * determine the toxicity of topical sunscreen vs placebo in these patients. * determine whether discontinuation of treatment intervention is followed by rash development. outline: this is a multicenter, randomized, double-blind, placebo-controlled study. patients are stratified according to chemotherapy regimen (first-line chemotherapy vs other), epidermal growth factor receptor (egfr) inhibitor therapy (small molecule vs monoclonal antibodies), concurrent medication that increases sun hypersensitivity (yes vs no), and gender. patients are randomized to 1 of 2 treatment arms. * arm i: patients apply sunscreen generously to the entire body twice daily for 4 weeks. * arm i: patients apply placebo generously to the entire body twice daily for 4 weeks. patients complete self-reported questionnaires regarding their rash status at baseline and then weekly for 8 weeks. after completion of study treatment, patients are followed for 8 weeks.

Eligibility criteria:
disease characteristics: * diagnosis of cancer * receiving ≥ 1 of the following epidermal growth factor receptor (egfr) inhibitor treatments: * gefitinib * cetuximab * erlotinib * panitumumab * icr-62 * matuzumab * ci-1033 * egfr treatment must have begun within the past 3 days * no rash (of any etiology) at study entry patient characteristics: * able to apply sunscreen on face, trunk, and extremities * able to complete questionnaire(s) * no history of allergic reactions or severe intolerance to sunscreen or its derivatives * no history of skin problems likely to reoccur during treatment * must avoid heavy sun exposure, especially during the hours of noon to 4 pm daily prior concurrent therapy: * see disease characteristics * no concurrent tanning bed usage * no other concurrent topical sunscreens

Keywords: dermatologic complications unspecified adult solid tumor, protocol specific
multiple dose healthy volunteer safety pharmacokinetics study

Conditions: Chronic Obstructive Pulmonary Disease

Summary: multiple dose safety and pharmacokinetics in healthy male subjects


Eligibility criteria:
inclusion criteria: * healthy male subjects between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ecg and clinical laboratory tests). * body mass index (bmi) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs). a bmi lower limit of 17.5 kg/m2 may be rounded up to 18.0 kg/m2; a bmi upper limit of 30.5 kg/m2 may be rounded down to 30.0 kg/m2 and will be acceptable for inclusion. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening. * any condition possibly affecting drug absorption (eg, gastrectomy).

Keywords: multiple dose safety and pharmacokinetics study
effects of active stretching on cardiovascular response and arterial stiffness in older adults with low flexibility

Conditions: Arterial Stiffness; Autonomic Nervous System; Musculoskeletal Diseases; Range of Motion

Summary: a study of the effects of active static stretching exercise in elderly people with poor lower extremity muscle flexibility on autonomic and cardiovascular responses and balance ability.

this study aims to investigate the effects of active static stretching exercises on autonomic nervous system responses, arterial stiffness, and balance ability in elderly individuals with poor flexibility in the lower extremity muscles. participants will engage in an 8-week exercise program consisting of active static stretching sessions, focusing on major muscle groups in the lower limbs. the intervention is designed to improve arterial elasticity and heart rate variability (hrv) while enhancing dynamic and static balance performance. outcomes will include measures of heart rate variability (hrv), arterial stiffness, and physical performance assessments such as the timed up and go test (tug), single-leg stance test (slst), and muscle strength tests. body composition and flexibility (sit-and-reach test, back scratch test) will also be evaluated. the study hypothesizes that active static stretching will promote improvements in autonomic regulation and cardiovascular health, as well as increase flexibility and balance control in community-dwelling older adults with reduced lower-limb flexibility.

Eligibility criteria:
inclusion criteria: * - elderly males and females * have a normal body mass index (between 18.5-24.5 kg/m2) * be able to follow instructions and willing to participate in the study * be able to communicate with the researcher and provide information by themselves (the researcher will read the questions to the volunteers and let the volunteers choose the answers by themselves) * be able to walk continuously for at least 10 meters with or without walking aids * have low flexibility with a forward lean distance not exceeding the 40th percentile from the sit and reach test according to the american college of sports medicine criteria exclusion criteria: * - abnormalities such as pain or inflammation of the legs more than 5 points, assessed by (visual analog scale (vas) \> 5 points) * significantly different leg lengths (more than 1.4 centimeters) or abnormalities of joints, including abnormal sensations that affect movement and walking * uncontrolled chronic diseases or obstacles to study, such as high blood pressure, diabetes, asthma, neurological diseases such as parkinson's disease, alzheimer's disease, skeletal and muscular diseases such as chronic back pain, acute osteoarthritis, sprained ankle * vision problems that cannot be corrected by wearing glasses * uncorrected hearing inner ear disturbances that affect balance, such as otitis media

Keywords: active static stretching arterial stiffness autonomic nervous system response lower-limb flexibility balance control in older adults
dna vaccine for ragweed allergic adults

Conditions: Seasonal Allergic Rhinitis

Summary: various chemical modifications of allergens have been attempted to enhance efficacy, improve safety, and foster compliance with it. these approaches have been unsuccessful - in that the allergenicity and immunogenicity have either decreased, or increased in tandem, with no resultant efficacy: safety benefit ratio. this study utilizes an adjuvant approach in which synthetic immunostimulatory dna is conjugated to ragweed allergen in an attempt to modulate both the clinical and immunologic allergic response to ragweed exposure in ragweed-allergic patients with seasonal rhinitis.

evaluation of efficacy and safety of allergen-cpg oligonucleotide immunostimulatory conjugate in treatment of ragweed-induced seasonal allergic rhinitis. study incorporates clinical outcomes (symptom diaries, medication diaries, visual analog scores, quality of life questionnaires), safety measurements, immunologic assays (antibody measurements, t-cell assays, cytokine assays, nasal provocation).

Eligibility criteria:
inclusion criteria: * adult men and women 18 to 60 years of age; * who provide informed consent; * have a history of fall, seasonal, allergic rhinitis consistent with ragweed allergy; * exhibit a positive skin test to licensed , standardized, ragweed extract and a positive acute response to ragweed nasal challenge; * are in general good health; and are available for the duration of the study. exclusion criteria: * individuals with medical conditions or taking medications that might interfere with interpretation of the study results will be excluded. * those with a history of severe symptoms of allergic rhinitis during the spring and summer grass pollen season will be excluded.

Keywords: cpg oligonucleotide vaccine ragweed immunotherapy
flooring for injury prevention trial

Conditions: Accidental Falls; Bone Fracture; Traumatic Brain Injury; Head Injuries, Closed; Nursing Homes

Summary: this study will evaluate the efficacy of novel compliant flooring in reducing injuries due to falls in a long-term care facility, determine the cost effectiveness of this intervention, and assess perceptions about compliant flooring among staff, residents, and families. the investigators hypothesize that compliant flooring will (1) reduce the incidence of injuries due to falls in long-term care residents; (2) represent an overall cost-savings when material and implementation costs are considered relative to direct and indirect costs associated with injuries due to falls; and (3) be received positively by staff, residents, and their family members.

falls are the number one cause of unintentional injury among older adults in canada, and are responsible for economic costs in excess of $1 billion cad annually. in high-risk environments, such as long-term care (ltc) facilities, 60% of residents will experience at least one fall each year. moreover, approximately 30% of falls in ltc residents result in injury, and 3 to 5% cause fractures. a promising strategy for reducing the incidence of fall-related injuries in ltc facilities is to decrease the stiffness of the ground surface, and the subsequent force applied to the body parts at impact. purpose-designed compliant flooring can reduce the force applied to the hip during a fall by up to 35 % (to allow a raw egg to be successfully bounced without cracking). yet, few ltc facilities have flooring designed to reduce the impact of falls. this study will address this gap. resident rooms at a local ltc facility will be randomly assigned to installation of compliant flooring or control (non-compliant) flooring. following installation, primary and secondary outcomes, including fall-related injuries and falls, will be monitored for 4 years and compared between resident rooms with and without compliant flooring. in addition, health resource utilization and their costs will be compared between resident rooms with and without compliant flooring. perceptions about compliant flooring will be assessed among staff, residents, and their families.

Eligibility criteria:
inclusion criteria (for rooms): * resident rooms across four units at new vista society care home, a long-term care facility in burnaby, bc, canada exclusion criteria (for rooms): * resident rooms across four units at new vista society care home in which new flooring cannot be installed

Keywords: falls fall injuries bone fracture hip fracture skull fracture wounds closed head injury traumatic brain injury concussion spinal cord injury trauma older adults long-term care compliant flooring safety floors balance injury biomechanics biomedical engineering environmental hazards environmental interventions fall prevention gerontology
efficacy of dihydroartemisinin for treating female androgenetic alopecia

Conditions: Androgenetic Alopecia (AGA)

Summary: the goal of this clinical trial is to learn if dihydroartemisinin (dha) works to treat androgenetic alopecia (aga) in female adults. the main question it aims to answer is: • does dha increase terminal hair follicles in the vertex area. researchers will compare oral dha plus topical minoxidil to topical minoxidil alone in female patients with aga to see if dha works to alleviate aga. participants will: * receive oral dha every day plus topical minoxidil or use topical minoxidil alone for 6 months. * visit the clinic once every month for checkups and tests.


Eligibility criteria:
inclusion criteria: * clinically diagnosed with androgenetic alopecia (aga) * no pregnancy plans within the next 6 months exclusion criteria: * patients who received systemic medications for hair loss within the past 2 months * use of topical medication for hair loss within the past 2 weeks * pregnancy or lactation * patients with known severe diseases of vital organs (e.g., heart, liver, kidney) or malignancies.

Keywords: androgenetic alopecia dihydroartemisinin
digital reminiscence for people with dementia

Conditions: Dementia

Summary: the purpose of this study is to explore the feasibility and acceptability of a digital reminiscence therapy (drt) intervention for people with dementia (pwd). the objectives of this study include: 1. to determine whether dtr can be delivered as planned in the care of pwd in jordanian care homes. 2. to determine whether dtr is acceptable/tolerable to pwd and care home staff in jordanian care homes 3. to identify the most appropriate outcome measures to evaluate the delivery of drt to pwd in jordanian care homes to be used in a subsequent definitive trial.

reminiscence therapy has been shown to be beneficial for people with dementia. the aim of this research is to develop and evaluate the feasibility of a digital application to aid reminiscence for people with dementia. this study proposes to design an application, based upon reminiscence therapy, which can act as storage for personal and communal 'positive memories' in a range of media types. this includes pictures, videos and audio. the target for this application is people with dementia and their staff caregivers. the study aims to recruit 40-50 participants (40 pwd and 10 staff caregivers). this research will look at the requirements for developing and evaluating a mobile application to see whether it might be used to aid reminiscence for people with dementia. additionally, this research will ensure whether this digital reminiscence therapy can be delivered and accepted as planned in the care of people with dementia in jordanian care homes. the acceptance of this digital reminiscence therapy will be assessed by using semi-structured interviews with approximately 15 people with dementia and staff care-givers. quantitative measures will be used before and after the intervention to explore whether certain outcomes are sensitive to change. these outcomes include memory, communication, anxiety, depression, and quality of life.

Eligibility criteria:
inclusion criteria: * people who have been clinically diagnosed with dementia determined by psychiatrist in the selected care homes. the diagnosis will be recorded in their care home notes. * people who are residents in the designated care home and they are anticipated to be resident in the care home for the coming year. * people who have the capacity to understand and consent to participate in the study (including those who can consent in the moment), or they will have a consultee who can be approached for their assent if they are not able to consent in the moment but meet the eligibility criteria. exclusion criteria: * people who are deemed too unwell to participate determined by care home staff. * people with a diagnosis of an additional psychiatric disorder other that those identified in the inclusion criteria (e.g. schizophrenia, mdd) determined by care home staff.

Keywords: dementia reminiscence therapy touch screen technology digital reminiscence therapy
a study to investigatethe safety, tolerability and efficacy of nebulised curosurf® in preterm neonates with respiratory distress syndrome (rds)

Conditions: Neonatal Respiratory Distress Syndrome

Summary: the present study will mainly aim at investigating the safety, tolerability and efficacy of different escalating single doses administration of nebulised curosurf®, in preterm neonates with rds (respiratory distress syndrome) during ncpap.

the study will be conducted in spontaneously breathing preterm neonates with mild to moderate rds and will consist of two parts: part i, with the objective to assess the safety and tolerability of single ascending doses of nebulised curosurf® ; part ii, with the objective to compare the efficacy of nebulised curosurf®, administered at two selected doses from part i, during ncpap, versus ncpap alone in terms of incidence of respiratory failure in the first 72 hours of life.

Eligibility criteria:
inclusion criteria: 1. written informed consent obtained by parents/legal representative (according to local regulation) prior to or after birth 2. inborn neonates from 28+0 to 32+6 weeks of gestational age (ga), spontaneously breathing and stabilised on ncpap 3. clinical course consistent with rds. 4. receiving cpap pressure 5-8 centimeter of water (cm h2o) and fraction of inspired oxygen (fio2) between 0.25 and 0.40 to maintain saturation of peripheral oxygen (spo2) between 88% and 95% for at least 30 minutes. randomization should occur between 60 minutes and 12 hours after birth. exclusion criteria: 1. early need for endotracheal intubation for cardiopulmonary resuscitation in delivery room or within 1 hour from birth because of severe rds 2. respiratory distress not secondary to surfactant deficiency 3. use of surfactant prior to study entry and need for endotracheal administration of any other treatment. 4. major congenital anomalies. 5. evidence of severe birth asphyxia 6. mothers with prolonged rupture of the membranes 7. presence of air leaks. 8. presence of ivh (intraventricular hemorrhage ) ≥ iii. 9. hypotension or evidence of hemodynamic instability. 10. any condition that, in the opinion of the investigator, would place the neonate at undue risk. 11. participation in another clinical trial

Keywords: rds
acceptability and efficacy of the zemedy app for irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this research is to assess if a new self-help app for ibs is an acceptable and effective intervention for improving the overall quality of life in patients with irritable bowel syndrome.


Eligibility criteria:
inclusion criteria: * diagnosis of ibs. own a smart phone. speak english exclusion criteria: * under age of consent (18) diagnosed with another gi disorder (e.g. celiac disease, inflammatory bowel disease)

Keywords: cognitive behavioral therapy self-help irritable bowel syndrome
laparoscopic donor nephrectomy score, a new scoring system for preoperative prediction of difficulty of laparoscopic donor nephrectomy

Conditions: Renal Failure Chronic; Surgery

Summary: the goal of this multicenter observational study is to develope and validate a new scoring system for preoperative prediction of difficulty of laparoscopic donor nephrectomy. healthy living kidney donors will be enrolled. the main questions it aims to answer are: 1) can the investigators predict difficulty of the operation ? 2) can the investigators score difficulty based on this new scoring system? difficulty of ldn will be graded by the operating surgeon at the end of the operation based on intraoperative predefined parameters. all operations will be blindly scored by the operating surgeon, while one radiologist will blindly review all preoperative ct scans. lapdoctor scores will be compared with the degrees of difficulty assigned by the operating surgeon to investigate the match rate.

the lapdoctor scoring programme calculates the score based on presence, absence of certain characteristics (sex, bmi, different radiologic measurements, etc.). a score of 1 to 2 is assigned to each characteristics . difficulty is graded as standard when the sum is between 11 and 18, moderately difficult between 19 and 25, very difficult between 26 and 33). at the end of the operation the donor surgeon will score the difficulty assigning a score of 1 to 3 to each phase of the operation, the resulting score will define again three degree of difficulty (standard 1-8, moderately difficult 9-16, very difficult 17-24.

Eligibility criteria:
inclusion criteria: - age of donor ≥ 18 yrs (minimum 18, maximum , deemed suitable for donation at the end of work-up exclusion criteria: * age\< 18 yrs * hypertension with organ damage * unable to express proper consent to procedure * evidence of coercion * drug abuse * evidence of malignancy * pregnancy * major respiratory or cardiovascular risk * diabetes mellitus * renal disease * systemic disease with renal involvement * thrombophilia * bmi \>35 * active infection * hepatitis b, hepatitis c and hiv

Keywords: living donation laparoscopic nephrectomy difficulty scoring system
mat pilates exercise program in patients with axial psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: the aim of this study is to investigate the effectiveness of mat pilates exercises on spinal mobility, spinal muscle endurance, disease activity, fatigue, emotional well-being, physical performance, and overall quality of life in psoriatic arthritis (psa) patients with axial involvement.

psoriasis is a chronic inflammatory skin disease commonly accompanied by joint involvement known as psoriatic arthritis (psa) \[1\]. psa is a subgroup of spondyloarthritis and is characterized by peripheral arthritis, dactylitis, enthesitis and spondylitis. axial involvement, which occurs in approximately 40% of psa patients may affect the entire spine, particularly the sacroiliac joint, leading to reduced cervical rotation, lateral flexion and anterior flexion of the spine \[2,3\]. exercise interventions in psa primarily aim to relieve pain, improve mobility and enhance functional capacity \[4\]. mat pilates exercises have been demonstrated as a safe and beneficial intervention in various rheumatic diseases, exhibiting significant improvements in functional status, fatigue, disease activity, pain, and overall quality of life \[5-7\]. additionally, pilates has been reported as effective in maintaining and enhancing spinal mobility \[8,9\]. however, despite these favorable outcomes, the efficacy of pilates exercises in psa remains unexplored. the aim of this study is to investigate the effectiveness of mat pilates exercises in psoriatic arthritis patients with axial involvement.

Eligibility criteria:
inclusion criteria: * being classified as psa according to caspar classification criteria * being between the ages of 18-65 * volunteering to participate in the study exclusion criteria: * any additional systemic disease other than psa * any other condition that may prevent participation/continuation of the exercise program or completion of the assessments * regular exercise habits (following a structured exercise program at least 3 days a week) * being included in a physiotherapy and rehabilitation program within the last 6 months

Keywords: pilates exercise arthritis spine mobility